RecruitingNot ApplicableNCT07070661

Radial Pressure Wave Therapy With or Without Parameter Modulation for Carpal Tunnel Syndrome.

Effects of Radial Pressure Wave Therapy Modulation in Patients With Carpal Tunnel Syndrome: A Double-Blind Randomized Clinical Trial.

Sponsor

Armando Tonatiuh Avila Garcia

Enrollment

60 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Carpal Tunnel Syndrome (CTS)

Summary

This study aims to evaluate the clinical effects of radial pressure wave therapy in patients with a confirmed diagnosis of mild to moderate carpal tunnel syndrome. Participants will be randomly assigned to receive radial pressure wave therapy using either a modulated or a constant parameter dosing protocol. The intervention consists of three weekly sessions, and outcomes will be assessed at baseline, 2 months, and 4 months after the first session. The primary outcome is pain intensity measured by the Visual Analog Scale, while secondary outcomes include functional status evaluated with the Boston Carpal Tunnel Questionnaire, grip strength, and electrodiagnostic parameters of the median nerve. The study is conducted in the Physical Medicine and Rehabilitation Service of the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde," and has been approved by the hospital's Ethics Committee.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

Adults aged 18 to 75 years.
Clinical diagnosis of carpal tunnel syndrome based on symptoms such as nocturnal paresthesia, numbness in the median nerve distribution, and/or thenar weakness.
At least one positive provocative test (e.g., Tinel's, Phalen's, or Durkan's test).
Symptoms present for at least 1 month.
NPRS (Numeric Pain Rating Scale) score ≥ 4 at baseline.
Able and willing to attend all intervention sessions and follow-up assessments.
Able to provide informed consent.

Exclusion Criteria8

Prior wrist surgery on the affected side.
Prior treatment with radial pressure wave therapy for CTS.
Diagnosis of polyneuropathy, cervical radiculopathy, or systemic conditions affecting nerve function (e.g., uncontrolled diabetes, hypothyroidism, rheumatoid arthritis).
Severe thenar atrophy or muscle wasting.
Pacemaker or other implanted electronic devices.
Pregnancy.
Currently participating in another clinical trial or intervention study.
Inability to understand or complete the study procedures.

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Interventions

DEVICEFixed-Dose Radial Pressure Wave Therapy.

Radial pressure wave therapy will be delivered using the BTL-6000 device. Parameters such as frequency and pressure will remain constant throughout each session. Each participant will receive one session per week for three weeks. The treatment will follow a standardized protocol previously established in the literature and based on patient tolerance.

DEVICEModulated-Dose Radial Pressure Wave Therapy.

The BTL-6000 device will be used to deliver therapy with dynamic modulation of frequency and/or pressure within each session, following a structured protocol aiming to optimize clinical response.